戻る Agenda
Session 9A: Interactive Discussion of CMC Challenges and Moving Forward
Session Chair(s)
Kim Tyndall
President
CMC Tyndall Consultant LLC, United States
Speaker(s)
Panelist
Ramesh Raghavachari, PhD
FDA, United States
Supervisor, Unit 3/DPQA IV/OPQA I/OPQ/CDER
Panelist
Ashley Boam, MS
FDA, United States
Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER
Panelist
René Thürmer, PhD
Federal Institute for Drugs and Medical Devices, Germany
Quality Assessor